-- Adaptive Platform Trial is Evaluating Drugs
and Investigational Products in the Treatment of Critically Ill
COVID-19 Patients --
Omeros Corporation (Nasdaq: OMER) and Quantum Leap Healthcare
Collaborative announced that dosing of patients with narsoplimab in
the I-SPY COVID-19 Trial began earlier this month. The I-SPY
COVID-19 Trial is an adaptive platform trial sponsored by Quantum
Leap Healthcare Collaborative. The goal of the trial is to screen
rapidly, in parallel, multiple promising agents in order to
identify drugs that will have a high impact on reducing mortality
and avoid or reduce the duration of mechanical ventilation for
critically ill COVID-19 patients.
“We’re excited that narsoplimab is one of the agents that has
entered the I-SPY COVID-19 Trial,” said Laura Esserman, MD, MBA,
co-founder of Quantum Leap Healthcare Collaborative, Principal
Investigator of the I-SPY trial program, and Professor of Surgery
and Radiology at the University of California – San Francisco. “The
mechanism of action, specifically targeting endothelial injury,
along with its safety profile and initial data generated in
critically ill COVID-19 patients make a compelling case for this
agent. The pulmonary and critical care investigators leading the
I-SPY COVID Trial uniformly endorsed narsoplimab and made it a
high-priority candidate for the trial. Together, we will be able to
generate data on the ability of the agent to reduce the time to
recovery and lower mortality.”
Narsoplimab is Omeros’ lead antibody targeting mannan-binding
lectin-associated serine protease-2 (MASP-2), the effector enzyme
of the lectin pathway of complement. It is the only complement
inhibitor invited to participate in the I-SPY COVID-19 Trial.
Narsoplimab has been administered under compassionate use to treat
severely ill COVID-19 patients requiring mechanical ventilation,
with impressive outcomes.
“Omeros is pleased to be working with Quantum Leap Healthcare
Collaborative in this important effort,” said Gregory Demopulos,
MD, Omeros’ chairman and chief executive officer. “With the
multiple variants of SARS-CoV-2 already spreading globally, it is
clear that vaccines alone likely will not be sufficient. Drs.
Esserman, Calfee, and Liu and their team have established an
innovative, efficient and rapidly enrolling platform trial to help
identify treatments that can be useful in the fight against
COVID-19, and we look forward to learning the outcomes of I-SPY
study patients treated with narsoplimab.”
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed
to discovering, developing and commercializing small-molecule and
protein therapeutics for large-market and orphan indications
targeting inflammation, complement-mediated diseases, disorders of
the central nervous system and immune-related diseases, including
cancers. Its commercial product OMIDRIA (phenylephrine and
ketorolac intraocular solution) 1%/0.3% continues to gain market
share in cataract surgery. Omeros’ lead MASP-2 inhibitor
narsoplimab targets the lectin pathway of complement and is the
subject of a biologics license application under priority review by
FDA for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy. Narsoplimab is
also in multiple late-stage clinical development programs focused
on other complement-mediated disorders, including IgA nephropathy,
atypical hemolytic uremic syndrome and COVID-19. Omeros’ MASP-3
inhibitor OMS906, which targets the complement system’s alternative
pathway, recently entered the clinic, and the company’s PDE7
inhibitor OMS527 has successfully completed its Phase 1 trial.
Omeros’ pipeline holds a diverse group of preclinical programs
including a novel antibody-generating technology and a proprietary
GPCR platform through which it controls 54 new GPCR drug targets
and their corresponding compounds. One of these novel targets,
GPR174, modulates a new cancer immunity axis recently discovered by
Omeros, and the company is advancing small-molecule GPR174
inhibitors. For more information about Omeros and its programs,
visit www.omeros.com.
About Narsoplimab
Narsoplimab, also known as “OMS721,” is an investigational human
monoclonal antibody targeting mannan-binding lectin-associated
serine protease-2 (MASP-2), a novel pro-inflammatory protein target
and the effector enzyme of the lectin pathway of complement.
Importantly, inhibition of MASP-2 does not appear to interfere with
the antibody-dependent classical complement activation pathway,
which is a critical component of the acquired immune response to
infection. Omeros controls the worldwide rights to MASP-2 and all
therapeutics targeting MASP-2.
A biologics license application (BLA) is under priority review
by the U.S. FDA for use of narsoplimab in the treatment of
hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA), and the drug is in Phase 3 clinical
programs for immunoglobulin A (IgA) nephropathy and atypical
hemolytic uremic syndrome (aHUS). The FDA has granted narsoplimab
breakthrough therapy designations for HSCT-TMA and for IgA
nephropathy; orphan drug status for the prevention (inhibition) of
complement-mediated thrombotic microangiopathies, for the treatment
of HSCT-TMA and for the treatment of IgA nephropathy; and fast
track designation for the treatment of patients with aHUS. The
European Medicines Agency has granted orphan drug designation to
narsoplimab for treatment in HSCT and for treatment of primary IgA
nephropathy.
About the I-SPY TRIALS
The I-SPY 2 TRIAL for stage II and III breast cancer is the
longest running and most successful adaptive platform trial in
oncology. Quantum Leap was able to use the existing I-SPY 2 TRIAL
infrastructure methodology to develop the I-SPY COVID Trial
(Investigation of Serial studies to Predict Your COVID Therapeutic
Response with biomarker Integration and Adaptive Learning). The
I-SPY COVID Trial is designed to rapidly screen promising
experimental treatments, and re-purpose existing agents to identify
the most effective treatments for severely ill COVID-19 patients.
The trial is a unique collaborative effort by a consortium that
includes the U.S. Food and Drug Administration (FDA), industry,
patient advocates, philanthropic donors, and clinicians from
multiple major U.S. research centers. Under the terms of the
collaboration agreement, Quantum Leap Healthcare Collaborative is
the trial sponsor and manages all study operations. For more
information, visit www.quantumleaphealth.org and
www.ispytrials.org.
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative (Quantum Leap) is a
501c(3) charitable organization established in 2005 as a
collaboration between medical researchers at University of
California, San Francisco and Silicon Valley entrepreneurs. Our
mission is to integrate high-impact research with clinical
processes and systems technology, resulting in improved data
management and information systems, greater access to clinical
trial matching and sponsorship, and greater benefit to providers,
patients, and researchers. Quantum Leap provides operational,
financial, and regulatory oversight to all I-SPY Trials. For more
information, visit www.quantumleaphealth.org.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, which are
subject to the “safe harbor” created by those sections for such
statements. All statements other than statements of historical fact
are forward-looking statements, which are often indicated by terms
such as “anticipate,” “believe,” “can,” “could,” “estimate,”
“expect,” “goal,” “intend,” “likely”, “look forward to,” “may,” “on
track,” “plan,” “potential,” “predict,” “project,” “prospects,”
“scheduled,” “should,” “slated,” “targeting,” “will,” “would” and
similar expressions and variations thereof. Forward-looking
statements, including statements regarding anticipated regulatory
submissions, the timing and results of ongoing or anticipated
clinical trials, and the therapeutic application of Omeros’
investigational product, are based on management’s beliefs and
assumptions and on information available to management only as of
the date of this press release. Omeros’ actual results could differ
materially from those anticipated in these forward-looking
statements for many reasons, including, without limitation, risks
associated with product commercialization and commercial
operations, unproven preclinical and clinical development
activities, the impact of COVID-19 on our business, financial
condition and results of operations, regulatory oversight, changes
in reimbursement and payment policies by government and commercial
payers or the application of such policies, intellectual property
claims, competitive developments, litigation, and the risks,
uncertainties and other factors described under the heading “Risk
Factors” in the company’s Annual Report on Form 10-K filed with the
Securities and Exchange Commission (SEC) on March 1, 2021, as
supplemented by our Quarterly Reports on Form 10-Q filed with the
SEC and subsequent filings with the SEC. Given these risks,
uncertainties and other factors, you should not place undue
reliance on these forward-looking statements, and the company
assumes no obligation to update these forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by applicable law.
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Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations 360.668.3701 jennifer@cwcomm.org
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